Evidence map›Paper›PMID 38675889›Full record

Trial reportViruses2024

No Remdesivir Resistance Observed in the Phase 3 Severe and Moderate COVID-19 SIMPLE Trials.

Charlotte Hedskog, Christoph D Spinner, Ulrike Protzer, Dieter Hoffmann, Chunkyu Ko, Robert L Gottlieb, Medhat Askar, Meta Roestenberg, Jutte J C de Vries, Ellen C Carbo and 17 more

Open access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Viruses, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
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  3. Oral lipid prodrug V2043 (1-Antimicrobial agents and chemotherapy · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 11 institutions in 7 countries.

Charlotte HedskogGilead Sciences, Inc., Foster City, CA 94404, USA.
Christoph D SpinnerTUM School of Medicine and Health, Department of Clinical Medicine-Clinical Department for Internal Medicine II, University Medical Center, Technical University of Munich, 81675 Munich, Germany.ORCID 0000-0002-3875-5367
Ulrike ProtzerGerman Center for Infection Research (DZIF), Munich Partner Site, 81675 Munich, Germany.ORCID 0000-0002-9421-1911
Dieter HoffmannGerman Center for Infection Research (DZIF), Munich Partner Site, 81675 Munich, Germany.
Chunkyu KoInstitute of Virology, Technical University of Munich School of Medicine, 81675 Munich, Germany.ORCID 0000-0001-6512-1602
Robert L GottliebCenter for Advanced Heart and Lung Disease, Department of Internal Medicine, Baylor University Medical Center, Dallas, TX 75246, USA.ORCID 0000-0001-8376-8709
Medhat AskarCenter for Advanced Heart and Lung Disease, Department of Internal Medicine, Baylor University Medical Center, Dallas, TX 75246, USA.
Meta RoestenbergLeiden University Medical Center for Infectious Diseases (LUCID), 2333 ZA Leiden, The Netherlands.ORCID 0000-0002-5052-2830
Jutte J C de VriesLeiden University Medical Center for Infectious Diseases (LUCID), 2333 ZA Leiden, The Netherlands.ORCID 0000-0003-2530-6260
Ellen C CarboLeiden University Medical Center for Infectious Diseases (LUCID), 2333 ZA Leiden, The Netherlands.
Ross MartinGilead Sciences, Inc., Foster City, CA 94404, USA.
Jiani LiGilead Sciences, Inc., Foster City, CA 94404, USA.
Dong HanGilead Sciences, Inc., Foster City, CA 94404, USA.
Lauren RodriguezGilead Sciences, Inc., Foster City, CA 94404, USA.
Aiyappa ParvangadaGilead Sciences, Inc., Foster City, CA 94404, USA.
Jason K PerryGilead Sciences, Inc., Foster City, CA 94404, USA.ORCID 0000-0001-5492-0652
Ricard FerrerVall d'Hebron Hospital Universitari, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Medicine Department, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.
Andrés AntónVall d'Hebron Hospital Universitari, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Medicine Department, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.ORCID 0000-0002-1476-0815
Cristina AndrésVall d'Hebron Hospital Universitari, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Medicine Department, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.
Vanessa CasaresVall d'Hebron Hospital Universitari, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Medicine Department, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.ORCID 0009-0005-2828-3318
Huldrych F GünthardDepartment of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, 8057 Zurich, Switzerland.ORCID 0000-0002-1142-6723
Michael HuberInstitute of Medical Virology, University of Zurich, 8057 Zurich, Switzerland.ORCID 0000-0002-0384-0000
Grace A McComseyDepartment of Medicine, University Hospitals of Cleveland and Case Western Reserve University, Cleveland, OH 44106, USA.
Navid SadriDepartment of Medicine, University Hospitals of Cleveland and Case Western Reserve University, Cleveland, OH 44106, USA.ORCID 0000-0001-5051-717X
Judith A AbergDepartment of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.ORCID 0000-0001-8162-0284
Harm van BakelDepartment of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Danielle P PorterGilead Sciences, Inc., Foster City, CA 94404, USA.
Gilead Sciences (United States) · USUniversitat Autònoma de Barcelona · ESLeiden University Medical Center · NLHelmholtz Zentrum München · DEIcahn School of Medicine at Mount Sinai · USUniversity Hospitals of Cleveland · USUniversity of Zurich · CHBaylor University Medical Center · USGerman Center for Infection Research · DETechnical University of Munich · DETexas A&M Health Science Center · US

Funding

Clinical and Translational Science Collaborative of Northern Ohio, Catalyzing Linkages to Equity in Health (CLE Health)UM1TR004528 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI GRACE A MCCOMSEY · 2023 to 2026
$32.1M
Gilead Sciences (United States) Not applicableNCATS NIH HHS UM1 TR004528
6 · The paper itself

Abstract

Remdesivir (RDV) is a broad-spectrum nucleotide analog prodrug approved for the treatment of COVID-19 in hospitalized and non-hospitalized patients with clinical benefit demonstrated in multiple Phase 3 trials. Here we present SARS-CoV-2 resistance analyses from the Phase 3 SIMPLE clinical studies evaluating RDV in hospitalized participants with severe or moderate COVID-19 disease. The severe and moderate studies enrolled participants with radiologic evidence of pneumonia and a room-air oxygen saturation of ≤94% or >94%, respectively. Virology sample collection was optional in the study protocols. Sequencing and related viral load data were obtained retrospectively from participants at a subset of study sites with local sequencing capabilities (10 of 183 sites) at timepoints with detectable viral load. Among participants with both baseline and post-baseline sequencing data treated with RDV, emergent Nsp12 substitutions were observed in 4 of 19 (21%) participants in the severe study and none of the 2 participants in the moderate study. The following 5 substitutions emerged: T76I, A526V, A554V, E665K, and C697F. The substitutions T76I, A526V, A554V, and C697F had an EC

Indexed as

Adenosine MonophosphateAlanineAntiviral AgentsCOVID-19COVID-19 Drug TreatmentDrug Resistance, ViralSARS-CoV-2Viral LoadFemaleHumansMaleMiddle AgedRetrospective StudiesSeverity of Illness IndexAdenosine MonophosphateAlanineAntiviral AgentsremdesivirgenotypingNsp12phenotypingremdesivirresistanceSARS-CoV-2

Identifiers

PMID38675889
PMCPMC11053423
OpenAlexW4393356674

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.